Implementing the WHO PIP Framework – Industry’s Role & Outlook

In May 2011, the World Health Organization (WHO) adopted the Pandemic Influenza Preparedness (PIP) Framework after nearly five years of contentious negotiations. As noted by Anne Huvos, WHO Secretariat, the two objectives of the PIP Framework are: (1) to improve sharing of influenza viruses with human pandemic potential; and (2) to achieve more predictable, efficient, and equitable access to benefits, such as vaccines and antiviral medicines, during future pandemics. The subject of a session at the 2012 BIO International Convention was the ongoing implementation of the PIP Framework and implications for the biotechnology industry.

Jane Earley, Director of the Health Team at the International Trade Administration, moderated the session and stressed the importance of industry having a voice during the implementation phase. From industry, Michael Watson, Vice President of Sanofi Pasteur, and Stanley Erck, President and CEO of Novavax, discussed the impact on large and small vaccine companies respectively. The Framework requires companies who receive PIP biological materials (e.g. pandemic influenza strains) from the WHO global influenza surveillance and response system (GISRS) to make annual financial contributions to WHO, and to donate products (e.g. vaccines, antivirals, diagnostic kits) and comply with other obligations outlined in Standard Material Transfer Agreements. Erck raised concerns about these contributions, noting that small biotech companies must raise money to fund the pre-clinical and clinical development of vaccines. Due to existing financial constraints, he argued, companies without licensed products should be exempt from annual financial contributions required by the PIP Framework.

Chris Colwell of Becton Dickinson represented the views of the diagnostics sector. He stated that some manufacturers of influenza diagnostics may only utilize the GISRS every few years, rather than annually, and implementation of the Framework should recognize the differences in GISRS use among industry segments. He also noted that while all manufacturers from all countries should participate in annual financial contributions, the size of the contributions should reflect the relative capacities of industry segments.

While panelists acknowledged the many questions that remain regarding implementation, Robert Sorenson of the U.S. Department of State encouraged industry to stay actively involved during the coming months. Watson concurred, stating that close cooperation and partnership between WHO, industry, and other stakeholders are key to the success of the PIP Framework. The Framework represents a novel approach to pandemic preparedness. If successful, it could increase the world’s capacity to respond to an influenza pandemic. However such success could create new problems. As Rick Bright of the Biomedical Advanced Research and Development Authority pointed out, an oversupply of vaccines and other products is a risk. In order to sustain new capacities, there must be a global demand for influenza vaccines, both seasonal and pandemic, and countries must be invested in domestic influenza vaccination programs.